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| Name | Class |
|---|---|
| University Hospital Dresden | OTHER |
| University of Leipzig | OTHER |
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The goal of this clinical trial is to test the performance of neuronal networks trained on ultrasonic raw Data (=radiofrequency data) for the assessment of liver diseases in patients undergoing a clinical ultrasound examination. The general feasibility is currently evaluated in a retrospective cohort.
The main questions the study aims to answer are:
To answer these questions participants with a clinically indicated fibroscan will undergo:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastography | Experimental | Collection of ultrasound data and elastography data from patients who were clinically planned for elastography |
|
| Focal lesion | Experimental | Collection of ultrasound data of the suspected lesion and a definitive diagnosis based on either normal ultrasound investigation or if not sufficient additional investigations like CEUS, Biopsy, MRI or CT. This further investigation should be in accordance to normal clinical routine of the centers to differentiate focal lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of elastography data | Device | patients who are scheduled for an elastography for clinical reasons usually receive an ultrasound scan in which the b-mode images of the liver tissue are collected. In this study additional radiofrequency data is collected through a software access. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance analysis of the trained model | Analysis of the concordance of a Deep Learning-based analysis of RF data with established clinical measures. In case of diffuse disease the stiffness of the tissue and in case of the focal lesions the underlying disease as diagnosed by the local physicians are the measures. Performance is evaluated by the area under the receiver operating characteristic curve and a correlation coefficient. | After study completion, estimated 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moritz Herzog, MD | Contact | 0049 351 458 11501 | moritz.herzog@ukdd.de |
| Name | Affiliation | Role |
|---|---|---|
| Moritz Herzog, MD | University Hospital Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Dresden | 01307 | Germany |
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| Label | URL |
|---|---|
| Webpage of the project with updated information, participating partners and resulting publications | View source |
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After the publication of data the anonymized IPD will be provided.
after finishing the study, data will be stored locally for at least 7 years
contact the investigators via mail
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2024 | Mar 15, 2024 |
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Data is collected in a defined group of patients (all patients listed for elastography or for ultrasonic investigation due to a focal lesion in participating departments). Afterwards performances of algorithms are compared based on this group.
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|
| Collection of ultrasonic raw data | Device | Patients who are transferred to the ultrasound departement due to suspicious focal lesions receive an ultrasonic investigation including the acquisition of raw data and extracting a definitive diagnose from the following clinical routine investigation, depending on the standards of the participating center |
|
| Diakonissen Hospital Dresden | Recruiting | Dresden | Germany |
|
| University Hospital Halle (Saale) | Recruiting | Halle | Germany |
|
| University Hospital Leipzig | Recruiting | Leipzig | Germany |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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